Wholesale China Pharmaceutical Purified Water & WFI System - Reliable Suppliers & Factory Solutions for Quality Water Production Manufacturers, Manufacturer

Introducing our pharmaceutical-grade water system, meticulously designed for pharmaceutical enterprises, formulation workshops, and active pharmaceutical ingredient (API) production lines in China. As one of the leading suppliers in the industry, our factory utilizes a proven process flow that includes pretreatment, precision filtration, reverse osmosis (RO), and EDI (electrodeionization). This innovative system guarantees long-term, stable production of high-quality pharmaceutical purified water.

The architecture of our water system fully complies with pharmaceutical engineering standards, ensuring that it meets stringent online monitoring, validation requirements, and operational safety criteria. This makes it ideal for continuous production conditions in the pharmaceutical industry.

With a focus on automation, our modular system enables online monitoring of critical parameters such as conductivity, temperature, and flow rate. As a result, it ensures stable water quality and provides traceable data that fulfills the core requirements of purified water systems—being controllable, monitorable, and verifiable. Trust our factory in China for your pharmaceutical-grade water solution needs.

Product Description

Our Solution

Shanghai Tongjie Environmental Protection provides a full range of pharmaceutical water systems, covering purified water (PW), water for injection (WFI), and pure steam, fully compliant with China Pharmacopoeia, USP, EP, FDA, and EU GMP standards. The systems employ a two-stage RO + EDI + multi-effect distillation process, featuring a 316L stainless steel sanitary-grade design, electrolytic polishing, automatic welding, and dead-angle <3D. They are equipped with pasteurization/SIP pure steam sterilization, CIP online cleaning, and online monitoring of TOC, conductivity, and microbiology. With over 10 years of experience in the pharmaceutical industry, the company delivers comprehensive validation documentation packages (DQ/IQ/OQ/PQ) to assist pharmaceutical enterprises in passing certification audits on the first attempt.

Core Advantage (Digitalization)

Pharmacopoeial-grade water quality

Conductivity ≤1.3 μS/cm, TOC ≤500 ppb, and endotoxin <0.25 EU/mL; Water for Injection fully complies with WFI standards.

Health-grade sterile design

316L EP piping, automatic welding + passivation, dual-sealed sterile storage tank, and fully circulating system with no dead zones.

Fully automated sterilization

Utilizes pasteurization and pure steam SIP sterilization, along with regular automatic disinfection to eliminate microbial growth.

Complete GMP Validation Package

A complete GMP validation package ensures hassle-free audits, providing 3D drawings, material certifications, welding records, and the full set of validation documents including DQ/IQ/OQ/PQ.

Modular Skid Design

The modular skid design enables rapid installation and requires minimal floor space. With factory prefabrication and pre-commissioning, only pipeline connections are needed on-site, allowing production launch within 30 days and reducing civil construction work by 70%.

An ideal solution for meeting short-term or long-term decentralized water supply demands
Contact Now

Standards & Regulations

Pharmaceutical water systems must strictly comply with the following standards and regulatory requirements:

  • EU/FDA/GMP Standards: Fully compliant design.
  • Purified Water Conductivity: ≤ 1.3 μS/cm (at 25°C).
  • TOC Limit: ≤ 500 ppb.
  • Microbial Limit: ≤ 100 CFU/ml.
  • GMP (Good Manufacturing Practice): Online monitoring, risk control, and verification capabilities.
  • Technical Guidelines for the Design and Validation of Water Systems.

Application Scenarios

  • Water for Injection (WFI): Preparations for injections, biologics, vaccines, and blood products.
  • Purified Water (PW): Tablets, capsules, oral solutions, medical device cleaning, and laboratory applications.
  • Pure Steam System: Sterilizer cabinet, pipeline sterilization, and process gas.
  • TCM / Biopharmaceuticals: Water used for fermentation, extraction, concentration, and chromatography.

Core Technical Parameters

Water Type Purified Water / Water for Injection (WFI)
Water Production Rate 500 L/h to 50 m³/h (Customizable)
Resistivity ≥1 MΩ·cm (PW & WFI)
TOC ≤500ppb (PW) / ≤100ppb (WFI)
Endotoxin <0.25 EU/mL (WFI)
Material 316L Stainless Steel (Sanitary Grade)
Control System PLC Fully Automatic + Remote Monitoring + Audit Tracking

Frequently Asked Questions

QDoes the system support continuous year-round production?

A: Yes. It operates fully automatically 24/7 with redundant design, featuring automated sterilization/cleaning processes to ensure uninterrupted operation throughout the year.

QCan you provide the complete GMP validation documentation?

A: Yes. We offer a comprehensive DQ/IQ/OQ/PQ validation package, including 3D models, material certificates, welding records, cleaning validation, and sterilization validation.

QDoes the system support CIP/SIP?

A: The system features standard CIP online cleaning and SIP pure steam sterilization, meeting the highest requirements for sterile pharmaceutical production.

QWhat specific water quality standards are met by your purified water system?

A: Our systems strictly comply with the China Pharmacopoeia, USP, EP, FDA, and EU GMP standards, delivering purified water with conductivity ≤ 1.3 μS/cm (at 25°C), TOC ≤ 500 ppb, and microbial limits ≤ 100 CFU/ml.

QHow does the modular skid design reduce project execution time?

A: The system is prefabricated and pre-commissioned at our factory. Only simple pipeline connections are required on-site, which allows the system to launch production within 30 days and reduces on-site civil construction work by 70%.

QWhat piping and structural features prevent microbial contamination?

A: We design the system with 316L EP (electrolytic polished) sanitary-grade stainless steel piping, automatic welding with passivation, dual-sealed sterile storage tanks, and a fully circulating layout with dead-angles <3D to completely prevent microbial growth.

Other Products

Modular Containerized Seawater Desalination Equipment

Modular Containerized Seawater Desalination...

Seawater desalting equipment

Seawater desalting equipment

High-Salinity Wastewater Volume Reduction & ZLD System

High-Salinity Wastewater Volume Reduction...

OEM Precision Manufacturing

OEM Precision Manufacturing

ODM Full Value Chain Innovation

ODM Full Value Chain Innovation

Water Reuse Equipment

Water Reuse Equipment (Pretreatment + UF + RO)

Water Reuse Equipment High-Ratio Water Reuse Process

Water Reuse Equipment High-Ratio Water...

Industrial Demineralized Water Equipment

Industrial Demineralized Water Equipment

Send Inquiry

Related Products